In today’s pharmaceutical industry, unique problems are common and almost guaranteed to arise. BioConvergence provides consultant services for a number of needs where a solution may not yet be visible. No matter how large or small the project may be, we can create a custom solution to your consulting needs. Our experience and expertise lies in these areas:
- Lyophilization Optimization
- Method Development, Qualification, and Validation
- Facility Design, Project Management, and Startup
- Manufacturing Equipment, Design, Vendor Selection, Factory Acceptance Testing & Installation
- Inspection & Packaging Equipment Design, Vendor Selection
- Master Plan Creation & Review
- Equipment & Critical Utility IQ/OQ/PQ
- Technical Transfer
- Person-in-Plant Oversight during Manufacturing, Inspection, Labeling, & Packaging
- Quality System and cGMP Compliance Assessment
- Person-in-Plant Oversight
- Vendor Audits & Qualification
- Regulatory Response Review
For more information or to begin your consultation, contact us.
